DCFPyL (Piflufolastat)

P015
Grade:
GMP product
Tested for sterility and bacterial endotoxins
Description:
Chemical precursor for ¹⁸F-DCFPyL.
Used in PET-CT diagnostics of metastatic castration-resistant prostate cancer.
This method is 44% more sensitive in detecting nodular and distant metastases at early stages in patients with intermediate to high-risk prostate cancer.
Synonyms:
Piflufolastat
Molar weight:
442.40 g/mol (net substance)
Molecular formula:
C₁₈H₂₃FN₄O₈ (net substance)
CAS №:
1423758-00-2
PubChem CID:
71719984
Retest date:
Not less than 18 months from the manufacturing date
Packaging:
2R/4ml or 8R/10ml Type I glass vials with bromobutyl rubber stoppers
Storage conditions:
–20 ±5 °C
Transportation at 2–8 °C (less than 1 month)
Available quantities:
0.1 mg; 1.0 mg; custom quantity upon request
Quality parameters

Quality parameters

Appearance: White solid
Identification:
– HPLC: Retention time of main peak corresponds to the DCFPyL reference standard
– Mass spectrometry: m/z = 442.4 ± 4
Residual heavy metals (ICP-OES): ≤ 100 ppm
Purity (HPLC): ≥ 98.0%
Bacterial endotoxins (gel-clot method): ≤ 10.0 EU/vial
Sterility (direct inoculation method): Sterile (passes test)
Sterility tests are performed for sterile products, made in aseptic conditions (class A).
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